Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome (SONO)

February 5, 2019 updated by: Chun Kee Chung, Seoul National University Hospital

Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. In the present study, the investigators are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. The tissue selectivity of ultrasonic osteotomy may enhance operative time and reduce tissue trauma. Moreover, bony fusion rate may be increased because of low thermal injury to the bone. In the present study, we are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL;
  2. aged more than 20 years
  3. with American Society of Anesthesiology physical status class 1 or 2

Exclusion Criteria:

1) concomitant neurological disease such as cerebral palsy or amyotrophic lateral sclerosis; 2) concurrent cancer or infection; 3) previous cervical spinal surgery; 4) a trauma-associated lesion; 5) inability to be followed up (i.e., foreign patients); 6) refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasonic osteotome
making gutter on the hinge side of lamina with ultrasonic osteotome
Device: ultrasonic osteotome
making gutter with ultrasonic osteotome
Other Names:
  • misonix
Sham Comparator: Drill
making gutter on the hinge side of lamina with conventional drill
Device: drill
making gutter with drill
Other Names:
  • electronic drill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone fusion rate
Time Frame: 6 months
bony continuity on both ventral and dorsal laminaa
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding amount
Time Frame: during operation
bleeding amount through suction and gauze
during operation
fracture of laminar
Time Frame: during operation
the number of fractured lamina per patient
during operation
neck pain/arm pain
Time Frame: postop 1 year
Visual analogue scale
postop 1 year
Functional outcome
Time Frame: postop 1 year
Neck disability index
postop 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2015

Primary Completion (Actual)

February 4, 2018

Study Completion (Actual)

February 4, 2018

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SONO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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